The American Association for Clinical Chemistry (AACC) has raised concerns about New York regulators jumping the gun on draft federal regulations regarding the use of blood glucose meters in hospitals. A new directive by the New York State Department of Health requires that any provider using glucose meters for off-label purposes hold a state clinical laboratory permit for clinical chemistry and that only personnel licensed by the state Education Department are eligible to perform such testing. The state has determined that off-label use of a glucose meter is the equivalent of a high-complexity laboratory test and should be regulated accordingly. Off-label uses include the monitoring of patients in hospitals—whose blood glucose fluctuations may foretell some pending complications—as well as for screening for diabetes at health fairs and other community events. Although the AACC does not object to regulation of off-label uses of the meters, it is concerned that New York installed its own guidelines while the FDA is still hammering out a final version of its own rules. “AACC recognizes that there are many complicated and difficult decisions that must be made related to the use of blood glucose meters in off-label situations, such as who can perform the tests, […]
The American Association for Clinical Chemistry (AACC) has raised concerns about New York regulators jumping the gun on draft federal regulations regarding the use of blood glucose meters in hospitals.
A new directive by the New York State Department of Health requires that any provider using glucose meters for off-label purposes hold a state clinical laboratory permit for clinical chemistry and that only personnel licensed by the state Education Department are eligible to perform such testing. The state has determined that off-label use of a glucose meter is the equivalent of a high-complexity laboratory test and should be regulated accordingly.
Off-label uses include the monitoring of patients in hospitals—whose blood glucose fluctuations may foretell some pending complications—as well as for screening for diabetes at health fairs and other community events.
Although the AACC does not object to regulation of off-label uses of the meters, it is concerned that New York installed its own guidelines while the FDA is still hammering out a final version of its own rules.
“AACC recognizes that there are many complicated and difficult decisions that must be made related to the use of blood glucose meters in off-label situations, such as who can perform the tests, the settings in which these tests can be performed, and what types of studies are required,” said AACC Chief Executive Officer Janet B. Kreizman. “We recommend New York wait and consider the efforts to review this issue by [the Food and Drug Administration (FDA)], as well as the Centers for Medicare and Medicaid Services, before making and implementing policy changes that will significantly impact hospitals within their state and possibly nationwide.”
Although New York state decisions regarding laboratory regulations are not binding on other states, organizations with CLIA deeming authority often do look at regulatory moves that are made in the state as potential guidelines as part of their own decisionmaking process.
For better or for worse, glucose meters have become a staple of both consumer and clinical health care as diabetes has become a nearly endemic condition in the United States. The devices, which often cost as little as $10, are used by millions of Americans every day to monitor their blood sugar. A variety of studies have shown that monitoring of blood glucose in the hospital setting—whether the patient is diabetic or not—can provide an additional vital sign that can help reduce complications and often shorten average lengths of stay.
However, there have been concerns about the use of the meters in the hospital setting, particularly regarding the potential spread of hospital-acquired infections when the devices are not properly cleaned between uses, and the accuracy of the readings they provide when used during the care of critically ill patients.
In January, the FDA issued draft guidelines regarding how such devices should be designed and used in the hospital setting. Although the FDA has yet to issue final guidelines, the New York state directive is being implemented as if the guidance is final, according to James Nichols, a professor of pathology at Vanderbilt University and chair of the AACC’s governmental relations committee.
As a result of the change, Nichols noted that many hospitals in New York would be forced to utilize far more costly blood gas or alternative analyzers. There might be 10 blood gas analyzers in a hospital at any given time, versus 100 or more blood glucose meters, necessarily limiting availability of testsing if glucose meters can no longer be utilized for intensive insulin management.
The New York regulation also prohibits staff that had been routinely monitoring blood glucose levels from doing so—such as registered and licensed vocational nurses.
“It’s going to be a major impact,” Nichols said.
Although the AACC has asked New York to relent on its decision until the FDA makes its final determination, there has been no word yet on whether it might relent.
Takeaway: Even a fairly routine monitoring test can have implications for laboratory managers.
